Post-Operative PainPhase 2NCT02844725
Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain Following Gastrectomy
A Phase 2 study testing VVZ-149 injections in people with Post-Operative Pain, run by Vivozon, Inc. at 1 site in South Korea.
Trial summary
The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel, and placebo-controlled study. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Post-Operative Pain
- What is being tested?
- VVZ-149 injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient between the ages of 25 and 70 years old
- Male patient, in the case of female patient, postmenopausal women, or women physically incapable of childbearing
- Subject who underwent surgery specially for the clinical study
- Ability to provide written informed consent prior to any study procedures.
- Ability to understand study procedures and communicate clearly with the investigator and staff.
- Subjects with body weight under 100kg and body mass index (BMI) level lower than 35 kg/m2, inclusive
Who cannot join
- < Surgical Factors >
- Emergency or unplanned surgery.
- Repeat operation (e.g., previous surgery within 30 days for same condition).
- Cancer-related condition causing preoperative pain in site of surgery.
- < Subject Characteristics >
- Women with childbearing potential, Women who are pregnant or breastfeeding.
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- Chronic pain diagnosis (e.g., ongoing pain at baseline with NRS ≥ 4/10).
- Unstable or poorly controlled psychiatric condition (e.g., untreated PTSD, anxiety, or depression). Subjects who take stable doses (same dose >30 days) of antidepressants and anti-anxiety drugs may be included.
- Unstable or acute medical condition (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, AIDS).
- Subjects who have long PR (>200msec) or prolonged QTc (> 450msec in male, >470msec in female) at Screening
- < Drug, Alcohol, and Pharmacological Considerations >
- History of alcohol, opiate or other drug abuse or dependence within 12 months prior to Screening .
- Ongoing or recent (within 30 days prior to surgery) use of steroids, opioids, or antipsychotics.
- Alcohol consumption within 24 hours of surgery.
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen within 24 hours of surgery.
- Use of herbal agents or nutraceuticals (i.e., chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian) within 7 days prior to surgery.
- < Anesthetic and Other Exclusion Considerations >
- Use of neuraxial or regional anesthesia related to the surgery.
- Use of ketamine, gabapentin, pregabalin, or lidocaine (>1 mg/kg) intra or peri-operatively, or within 24 hours of surgery.
- Subject with known allergies to hydromorphone.
- Subjects who received another investigational drug within 30 days of scheduled surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Stdy to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain Following Laparoscopic or Robotic-assisted Laparoscopic Gastrectomy
The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel, and placebo-controlled study.
Read the detailed description
VVZ-149 is a dual antagonist of GlyT2 and 5HT2A. GlyT2 blockage increases inhibitory synaptic transmission by glycine in the spinal cord, resulting in a reduction of pain transmissions to the brain. 5HT2A blockage decreases descending serotonergic facilitatory modulation on pain transmission by the brain and reduces nociceptor activation in peripheral nerves, which are primary sources of pain in post-surgical pain. VVZ-149 has been shown to have comparable efficacy to morphine in well controlled (blind, complete randomization with a positive control) animal studies using rat models of post-operative pain and formalin-induced pain. The PK/PD study in animals indicates that therapeutic plasma concentration in human subjects will be 600-1,900 ng/ml. A clinical Phase 1 study performed in healthy subjects has shown no clinically significant adverse events up to a plasma concentration level of 3,261 ng/ml other than brief symptoms of mild nausea or dizziness, and mild somnolence when the plasma exposure level is more than 2,000 ng/ml.
- Conditions
- Post-Operative Pain
- Being tested
- VVZ-149 injections, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VVZ-149 injectionsDrug
Also called VVZ-149 injection
Colorless, transparent liquid in water for injection
PlaceboDrug
Also called water for injection
water for injection
| Study group | Role | What they receive |
|---|---|---|
| VVZ-149 injection | Experimental | VVZ-149 injections will be mixed with saline, then intravenous infusion for 10hr. The drug product will be administrated with a loading dose of 1.8 mg/kg for 0.5 hour followed by a maintenance dose of 1.3 mg/kg/h for 9.5 hours. Receives: Drug: VVZ-149 injections |
| Placebo | Placebo comparator | Placebo group will receive an water for injection the same volume and period of experimental group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain Intensity
Change of Pain Intensity assessed on the Numerical Rating Scale (NRS) using a 10-point scale up to 24 hours
Measured: prior toPCA, at 1, 2, 4, 6, 8, 10, 24 hours post-dose
Secondary outcomes (3)
Difference of Opioid Consumption between Study Groups
Measured: 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-16, 16-18, 18-20, 20-22, 22-24 hours post-dose
Pain Intensity Difference (PID) using Numerical Pain Rating Scale (NRS, 0-10) up to 24 hours
Measured: 1, 2, 4, 6, 8, 10, 24 hours post-dose
Global measurement of patient satisfaction assessed on the questionnarie (0-5 points scale)
Measured: 10, 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivozon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seonjun Bae, MD, PhD, Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844725
- Sponsor's protocol ID
- PT-VVZ149-05
- Status last verified
- Oct 2017
- First submitted
- 17 Jul 2016
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Stdy to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain Following Laparoscopic or Robotic-assisted Laparoscopic Gastrectomy
- ClinicalTrials.gov ID
- NCT02844725
- Acronym / sponsor ID
- PT-VVZ149-05
- Conditions
- Post-Operative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vivozon, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel, and placebo-controlled study.
Detailed description
VVZ-149 is a dual antagonist of GlyT2 and 5HT2A. GlyT2 blockage increases inhibitory synaptic transmission by glycine in the spinal cord, resulting in a reduction of pain transmissions to the brain. 5HT2A blockage decreases descending serotonergic facilitatory modulation on pain transmission by the brain and reduces nociceptor activation in peripheral nerves, which are primary sources of pain in post-surgical pain. VVZ-149 has been shown to have comparable efficacy to morphine in well controlled (blind, complete randomization with a positive control) animal studies using rat models of post-operative pain and formalin-induced pain. The PK/PD study in animals indicates that therapeutic plasma concentration in human subjects will be 600-1,900 ng/ml. A clinical Phase 1 study performed in healthy subjects has shown no clinically significant adverse events up to a plasma concentration level of 3,261 ng/ml other than brief symptoms of mild nausea or dizziness, and mild somnolence when the plasma exposure level is more than 2,000 ng/ml.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VVZ-149 injection | Experimental | Drug: VVZ-149 injectionsVVZ-149 injections will be mixed with saline, then intravenous infusion for 10hr. The drug product will be administrated with a loading dose of 1.8 mg/kg for 0.5 hour followed by a maintenance dose of 1.3 mg/kg/h for 9.5 hours. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo group will receive an water for injection the same volume and period of experimental group. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient between the ages of 25 and 70 years old
- Male patient, in the case of female patient, postmenopausal women, or women physically incapable of childbearing
- Subject who underwent surgery specially for the clinical study
- Ability to provide written informed consent prior to any study procedures.
- Ability to understand study procedures and communicate clearly with the investigator and staff.
Key exclusion criteria (21 listed)
- < Surgical Factors >
- Emergency or unplanned surgery.
- Repeat operation (e.g., previous surgery within 30 days for same condition).
- Cancer-related condition causing preoperative pain in site of surgery.
- < Subject Characteristics >
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VVZ-149 injectionsAlso: VVZ-149 injectionColorless, transparent liquid in water for injection | Drug | VVZ-149 injection |
| PlaceboAlso: water for injectionwater for injection | Drug | Placebo |
Primary outcome
Change of Pain Intensity
Time frame: prior toPCA, at 1, 2, 4, 6, 8, 10, 24 hours post-dose
Change of Pain Intensity assessed on the Numerical Rating Scale (NRS) using a 10-point scale up to 24 hours
3 secondary outcomes
Difference of Opioid Consumption between Study Groups
Time frame: 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-16, 16-18, 18-20, 20-22, 22-24 hours post-dose
Pain Intensity Difference (PID) using Numerical Pain Rating Scale (NRS, 0-10) up to 24 hours
Time frame: 1, 2, 4, 6, 8, 10, 24 hours post-dose
Global measurement of patient satisfaction assessed on the questionnarie (0-5 points scale)
Time frame: 10, 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seonjun Bae, MD, PhD principal investigator
Yonsei University Health System, Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VVZ-149 injections in people with Post-Operative Pain, run by Vivozon, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pain Intensity (time frame: prior toPCA, at 1, 2, 4, 6, 8, 10, 24 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.